In a late December 2020 press release, biopharmaceutical company Cerecor Inc. (“Cerecor”) announced the FDA acceptance of an Investigational New Drug Application (IND) for CERC-007. The human monoclonal antibody (mAb) therapy is designed for patients with adult-onset Still’s disease (AOSD).

CERC-007

Designed by Cerecor, CERC-007 is a human anti-IL-18 monoclonal antibody. According to the Mayo Clinic, monoclonal antibodies:

are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system’s attack on cancer cells. They are designed to bind to antigens that are generally more numerous on the surface of cancer cells than healthy cells.

In this case, CERC-007 binds to interleukin-18 (IL-18), a pro-inflammatory cytokine that plays a role in immune response. Within patients with AOSD, IL-18 is usually heightened. In addition to being developed for adult-onset Still’s disease, CERC-007 is being developed for multiple myeloma and systemic juvenile idiopathic arthritis.

Cerecor will evaluate CERC-007 for AOSD during its first Phase 1b clinical trial, which will take place near the start of 2021. Data from the study is also expected to be released within the 2nd quarter of the year, although that will ultimately depend on what progress is made. 12 patients will enroll. Overall, the clinical trial will evaluate the safety, efficacy, and tolerability of CERC-007 for patients with AOSD. 

Adult-Onset Still’s Disease

While the cause of AOSD is still unknown, many doctors believe that this rare autoinflammatory disorder is caused by certain antigens. Typically, AOSD affects patients between 15-25 or 36-46 years old. The condition is characterized by symptomatic flare-ups which can include fevers, rashes, and pain, interspersed with periods of remission. Symptoms include:

• A high fever which lasts for several days and gets worse at nights
• A salmon-colored skin rash
• Muscle, joint, and abdominal pain
• Arthritis
• Inflamed ankles and knees
• Unintended weight loss
• Sore throat
• Swollen lymph nodes
• Difficulty breathing
• Enlarged liver or spleen
• Inflamed heart and lung tissue

Learn more about AOSD.